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Efficacy of Different Types of Exercises in Women With Fibromyalgia Syndrome.

Primary Purpose

Fibromyalgia Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Supervised Aerobic Plus Stretching Exercises
Supervised Resistance Plus Stretching Exercises Group
Home-based Stretching Exercises Group
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia Syndrome focused on measuring Fibromyalgia, Aerobic exercise, Resistance exercise, Stretching exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Eligible participants who meet the criteria for inclusion were women with Fibromyalgia Syndrome diagnosis according to ACR 2016 Fibromyalgia Diagnostic Criteria and were 18-65 years old.
  • Participants were well communicative, motivated, and willing to participate in the study.

Exclusion Criteria:

• The exclusion criteria were the presence of uncontrolled hypertension, history of myocardial infarction or coronary artery disease, unstable angina pectoris, class 3-4 heart failure (New York Heart Association), musculoskeletal or systemic diseases contradicting the exercise, a neurological or psychiatric disease affecting cooperation and cognitive function, presence of active inflammation and immunosuppression.

Sites / Locations

  • Pamukkale University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Supervised Aerobic Plus Stretching Exercises Group

Supervised Resistance Plus Stretching Exercises Group

Home-based Stretching Exercises Group

Arm Description

The participants were instructed to perform the walking exercise at their target HR on a treadmill and stretching exercises before and after the exercise program in the Sports Rehabilitation Unit of Pamukkale University.

The participants were instructed to perform resistance exercises using weight machines and stretching exercises before and after the exercise program in the Sports Rehabilitation Unit of Pamukkale University.

The participants were instructed to perform the stretching exercises at home.

Outcomes

Primary Outcome Measures

Change from baseline in analogue scale (VAS) score at week 12
Pain intensity was measured with VAS for pain (0-10 cm; 0: no pain, 10: severe pain).
Change from baseline in Fibromyalgia Impact Questionnaire (FIQ) score at week 12
The Fibromyalgia Impact Questionnaire was designed to measure the health status of patients with fibromyalgia. Total score range from 0 to 100, with higher scores indicating higher levels of symptoms and severity.
Change from baseline Beck Depression Inventory (BDI) score (0-63) at week 12
This is a 21-item questionnaire that investigates the symptoms of depression. Total score range from 0 to 63, higher scores indicate higher levels of depression.
Change from baseline in Short Form 36 (SF-36) score at week 12.
Short- form health survey 36 contains 36 items which are used to evaluate the quality of life of patients. It measures eight different domains that address physical functioning, physical role limitation, body pain, general health, vitality, social functioning, emotional role limitation and mental health. The score of each domain ranges from 0 (worse quality of life) to 100 (best quality of life).
Change from baseline in weight (kilograms) at week 12.
Weight was measured with body composition analyzer (Tanita MC580).
Change from baseline in body mass index (BMI) at week 12
Height was measured with stadiometer and BMI was calculated with body composition analyzer (Tanita MC580).
Change from baseline in total body fat percentage at week 12
Total body fat percentage was measured with body composition analyzer (Tanita MC580).
Change from baseline in in total body muscle percentage at week 12.
Total body muscle percentage was measured with body composition analyzer (Tanita MC580).
Change from baseline in blood lactate concentration at rest (mmol/L) at week 12
Finger-stick capillary whole blood was collected at rest. Blood lactate concentration was performed using a lactate analyzer (Lactate Scout Plus)

Secondary Outcome Measures

Full Information

First Posted
June 8, 2020
Last Updated
September 14, 2020
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04426864
Brief Title
Efficacy of Different Types of Exercises in Women With Fibromyalgia Syndrome.
Official Title
Efficacy of Different Types of Exercises on Pain, Quality of Life, Depression, and Body Composition in Women With Fibromyalgia Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective: To demonstrate the most effective exercise intervention for women with fibromyalgia syndrome on the pain, quality of life, depression, and body composition through a comparative study of three types of exercise intervention: supervised aerobic plus stretching, supervised resistance plus stretching, and home-based stretching.
Detailed Description
Objective: To demonstrate the most effective exercise intervention for women with fibromyalgia syndrome on the pain, quality of life, depression, and body composition through a comparative study of three types of exercise intervention. Methods: Eighty-four patients women with fibromyalgia syndrome were assigned to three groups: supervised aerobic plus stretching exercises group (group I, n:28), supervised resistance plus stretching exercises group (group II, n:28) and home-based stretching exercises group (group III, n:28). The target heart rate (HR) corresponding to values of 50-70 % ergospirometric VO2max were determined by the submaximal treadmill test. Group I was instructed walking at their target HR on a treadmill. Exercise intensity in group II was determined by one-repetition maximum (1RM) measurements. Group III was instructed to exercise at home. All participants were instructed to perform stretching exercises. Before and after a 12-week exercise program, participants were evaluated by weight, Body Mass Index (BMI), total body fat and muscle percentage, Visual Analog Scale (VAS), Fibromyalgia Impact Questionnaire (FIQ), Short Form-36 (SF-36) and Beck Depression Inventory (BDI). Study Type: Interventional (Clinical Trial)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia Syndrome
Keywords
Fibromyalgia, Aerobic exercise, Resistance exercise, Stretching exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to three groups in parallel for the duration of the study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supervised Aerobic Plus Stretching Exercises Group
Arm Type
Active Comparator
Arm Description
The participants were instructed to perform the walking exercise at their target HR on a treadmill and stretching exercises before and after the exercise program in the Sports Rehabilitation Unit of Pamukkale University.
Arm Title
Supervised Resistance Plus Stretching Exercises Group
Arm Type
Experimental
Arm Description
The participants were instructed to perform resistance exercises using weight machines and stretching exercises before and after the exercise program in the Sports Rehabilitation Unit of Pamukkale University.
Arm Title
Home-based Stretching Exercises Group
Arm Type
Experimental
Arm Description
The participants were instructed to perform the stretching exercises at home.
Intervention Type
Other
Intervention Name(s)
Supervised Aerobic Plus Stretching Exercises
Intervention Description
An exercise prescription was developed for each woman based on the data acquired from the baseline treadmill exercise test. Target HR corresponding to values of 50-70 % ergospirometric VO2max (moderate-intensity) was determined by the submaximal treadmill test. The participants were instructed to perform their exercises at 50 % of VO2max for six weeks. At seventh their exercise intensity was increased to target HR corresponding to 70 % of VO2max. HR was monitored by a Polar HR monitor (Polar Beat, Port Washington, NY). Stretching exercises were performed at the beginning and end of each exercise session. Each muscle group exercise was performed 3-4 times and each repeat was 30 seconds long. The muscle groups which were involved in stretching exercises were upper trapezius, rhomboid, hip flexor, hamstring, pectoral, piriformis, quadriceps, gastrocnemius, soleus, levator scapulae, hip adductor and tensor fasciae late muscles. The exercise program was applied 3 days a week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Supervised Resistance Plus Stretching Exercises Group
Intervention Description
According to the data obtained from 1-RM tests, an exercise prescription was developed for each woman. The participants were instructed to perform their exercises with 50% of 1-RM for six weeks. In the 7. week, weights were increased to 70-80% of 1-RM. The number of sets increased progressively (10 repetitions per set; 1 set in the first two weeks; 2 sets in the 3rd and 4th week; 3 sets in the 5th and 6th week). The muscle groups which were involved in resistance exercises were bilateral biceps, deltoid, trapezius, pectorals, serratus anterior, latissimus dorsi, levator scapulae, rhomboid, gluteal, quadriceps, hip adductor and abductor, hamstring, gastrocnemius and abdominal muscles. Stretching exercises were performed at the beginning and end of each exercise session. Each muscle group exercise was performed 3-4 times and each repeat was 30 seconds long. Stretching exercises were given for the muscle groups they worked on. The exercise program was applied 3 days a week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Home-based Stretching Exercises Group
Intervention Description
Each exercise was described to the patient by visually. For each muscle group exercise was performed for 3-4 times and each repeat was 30 seconds long. The muscle groups which were involved in stretching exercises were upper trapezius, rhomboid, hip flexor, hamstring, pectoral, piriformis, quadriceps, gastrocnemius, soleus, levator scapulae, hip adductor and tensor fasciae late muscles. Exercise program was applied 3 days in a week during 12 weeks. Each participant was called every 2 weeks to maintain compliance.
Primary Outcome Measure Information:
Title
Change from baseline in analogue scale (VAS) score at week 12
Description
Pain intensity was measured with VAS for pain (0-10 cm; 0: no pain, 10: severe pain).
Time Frame
Week 12
Title
Change from baseline in Fibromyalgia Impact Questionnaire (FIQ) score at week 12
Description
The Fibromyalgia Impact Questionnaire was designed to measure the health status of patients with fibromyalgia. Total score range from 0 to 100, with higher scores indicating higher levels of symptoms and severity.
Time Frame
Week 12
Title
Change from baseline Beck Depression Inventory (BDI) score (0-63) at week 12
Description
This is a 21-item questionnaire that investigates the symptoms of depression. Total score range from 0 to 63, higher scores indicate higher levels of depression.
Time Frame
Week 12
Title
Change from baseline in Short Form 36 (SF-36) score at week 12.
Description
Short- form health survey 36 contains 36 items which are used to evaluate the quality of life of patients. It measures eight different domains that address physical functioning, physical role limitation, body pain, general health, vitality, social functioning, emotional role limitation and mental health. The score of each domain ranges from 0 (worse quality of life) to 100 (best quality of life).
Time Frame
Week 12
Title
Change from baseline in weight (kilograms) at week 12.
Description
Weight was measured with body composition analyzer (Tanita MC580).
Time Frame
Week 12
Title
Change from baseline in body mass index (BMI) at week 12
Description
Height was measured with stadiometer and BMI was calculated with body composition analyzer (Tanita MC580).
Time Frame
Week 12
Title
Change from baseline in total body fat percentage at week 12
Description
Total body fat percentage was measured with body composition analyzer (Tanita MC580).
Time Frame
Week 12
Title
Change from baseline in in total body muscle percentage at week 12.
Description
Total body muscle percentage was measured with body composition analyzer (Tanita MC580).
Time Frame
Week 12
Title
Change from baseline in blood lactate concentration at rest (mmol/L) at week 12
Description
Finger-stick capillary whole blood was collected at rest. Blood lactate concentration was performed using a lactate analyzer (Lactate Scout Plus)
Time Frame
Week 12

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participant eligibility is based on the self-representation of gender identity.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible participants who meet the criteria for inclusion were women with Fibromyalgia Syndrome diagnosis according to ACR 2016 Fibromyalgia Diagnostic Criteria and were 18-65 years old. Participants were well communicative, motivated, and willing to participate in the study. Exclusion Criteria: • The exclusion criteria were the presence of uncontrolled hypertension, history of myocardial infarction or coronary artery disease, unstable angina pectoris, class 3-4 heart failure (New York Heart Association), musculoskeletal or systemic diseases contradicting the exercise, a neurological or psychiatric disease affecting cooperation and cognitive function, presence of active inflammation and immunosuppression.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fusun ARDIC, Prof.M.D.
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Pamukkale University Faculty of Medicine
City
Denizli
ZIP/Postal Code
20070
Country
Turkey

12. IPD Sharing Statement

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Efficacy of Different Types of Exercises in Women With Fibromyalgia Syndrome.

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